Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-19 @ 9:45 AM
Study NCT ID:
NCT03047850
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-02-07', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Delta Pulse Pressure Value', 'timeFrame': '10 minutes', 'description': 'Change of Delta Pulse Pressure Value before and after sternotomy.'}, {'measure': 'Change of Delta Down Value', 'timeFrame': '10 minutes', 'description': 'Change of Delta Down before and after sternotomy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sternotomy'], 'conditions': ['Hemodynamics']}, 'descriptionModule': {'briefSummary': 'Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and Delta Down.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for open chest surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled for open chest surgery.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients with arrhythmia'}, 'identificationModule': {'nctId': 'NCT03047850', 'briefTitle': 'Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy', 'organization': {'class': 'OTHER', 'fullName': 'Astes'}, 'officialTitle': 'Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy', 'orgStudyIdInfo': {'id': 'DPPDD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'All patients included in this study.', 'interventionNames': ['Diagnostic Test: Comparison of Delta Down and Delta Pulse Pressure']}], 'interventions': [{'name': 'Comparison of Delta Down and Delta Pulse Pressure', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comparison of Delta Down and Delta Pulse Pressure Before and After Sternotomy.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5001', 'city': 'Bouge', 'state': 'Namur', 'country': 'Belgium', 'facility': 'Clinique Saint-Luc of Bouge', 'geoPoint': {'lat': 50.47193, 'lon': 4.89218}}], 'overallOfficials': [{'name': 'Eric DEFLANDRE, MD, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Astes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric DEFLANDRE, MD, FCCP', 'investigatorAffiliation': 'Astes'}}}}